Strides Pharma Inc — Class II drug recall D-0001-2021
Terminated recall by Strides Inc., reported 2020-10-07, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0001-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Strides Inc., Lambertville, NJ, United States |
| Recall initiated | 2020-08-24 |
| Classified | 2020-10-01 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2022-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 11,280 bottles |
| Reason classes | specification failure |
| NDC | 64380-0860, 64380-0860-06, 64380-0860-07, 64380-0860-08, 64380-0861, 64380-0861-06, 64380-0861-07, 64380-0861-08 |
| Expiration dates | 2021-12-31 |
Product
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06
Reason for recall
Failed Dissolution Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0001-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.